Validation of the warehouse,
Validation of the freezer, thermal container, and cold chain,
Validation of the online climate monitoring system for the warehouse,
Development of Standard Operating Procedures
- validation of the computerized system based on 1C,
- validation of warehouse areas,
- validation of the freezer, thermal container, and cold chain,
- validation of the online climate monitoring system for warehouse areas,
- the package of Standard Operating Procedures for QMS was developed
• Validation of the Microsoft Dynamics AX was conducted
05.2017
• Qualification of steam sterilizers Fluipharm 9 6 18-2H R, Steam Sterilizer STERIVAP HP IL
• Pure steam quality testing
07.2017
• Qualification of steam sterilizers Unisteri HP IL.
• Pure steam quality testing
• Qualifications were conducted
•Qualification of the clean rooms and laminars
• Qualification of ethylene oxide sterilizer
• Qualification was conducted
• Qualification was conducted
• Qualification of steam sterilizer
• Qualification of PW
• Qualifications were conducted
• Qualification of a computerized system for Shimadzu HPLC
• Qualification of the ampoule filling machine
• Qualification of ampoules filling machine
• GMP Audits
• Support in GMP certification
• Qualifications were performed
• Based on recommendations from consultants, many processes have been improved
• GMP Compliance Certificate was obtained
• GMP Certificate issued by the State Medicines Service of Ukraine was recognized by the Canadian Regulatory Authority
09.2016
• Qualification of steam sterilizer STERIVAP HP IL
02.2017
• Qualification of steam sterilizer Steam Sterilizer STERIMAT PLUS
• Pure steam quality testing
• Qualifications were conducted
• Qualification of steam sterilizer
• Qualification of a depyrogenation oven
• Qualifications were conducted